Table 2. Exclusion of kidney disease and reporting of renal function in cerebrovascular trials.
| All Trials n/N (%) |
Intervention was class I/II recommendation, Trials n/N (%) | |
|---|---|---|
| Overall | 135 (100) | 44/135 (32.6) |
| Excluding renal disease based on the index report, methods report or registered protocol | 48/135 (35.6) | 7/44 (15.9) |
| Threshold for exclusion* | ||
| Serum creatinine | 24/48 (50.0) | 2/7 (28.6) |
| • Serum creatinine > 1.3–2.0 mg/dL (115–177 μmol/L) | 6/48 (12.5) | 0/7 |
| • Serum creatinine ≥ 2.0–3.0 mg/dL (177–265 μmol/L) | 12/48 (25.0) | 1/7 (14.3) |
| • Serum creatinine ≥ 3.0 mg/dL (265 μmol/L) | 6/48 (12.5) | 1/7 (14.3) |
| eGFR | 4/48 (8.3) | 1/7 (14.3) |
| • eGFR ≤ 30 mL/min per 1.73 m2 | 3/48 (6.3) | 0/7 |
| • eGFR ≤ 60 mL/min per 1.73 m2 | 1/48 (2.1) | 1/7 (14.3) |
| CrCl | 3/48 (6.3) | 1/7 (14.3) |
| • CrCl ≤ 30 ml/min | 2/48 (4.1) | 0/7 |
| • CrCl ≤ 60 ml/min | 1/48 (2.1) | 1/7 (14.3) |
| eGFR or CrCl | 7/48 (14.6) | 2/7 (28.6) |
| • ≤ 30 | 5/48 (10.4) | 0/7 |
| • ≤ 60 | 2/48 (4.1) | 2/7 (28.6) |
| Renal replacement therapy | 7/48 (14.6) | 2/7 (28.6) |
| Nonspecific exclusion | 19/48 (39.6) | 4/7 (57.1) |
| Reporting baseline renal characteristics for each group in index report | ||
| • Baseline creatinine, eGFR or CrCl† | 4/135 (3.0) | 1/44 (2.3) |
| • Baseline creatinine | 4/135 (3.0) | 1/44 (2.3) |
| • Baseline eGFR | 0/135 | 0/44 |
| • Baseline CrCl | 0/135 | 0/44 |
| • Proportion of patients with renal disease | 3/135 (2.2) | 2/44 (4.5) |
| Trials planning subgroup analyses by renal characteristics in registered protocol or methods report, if any | 0/85 | 0/28 |
| Trials reporting subgroup analyses in index report | ||
| • At least 1 subgroup analysis by baseline characteristics | 69/135 (51.1) | 19/44 (43.2) |
| • At least 1 subgroup analysis by nonrenal characteristics | 69/135 (51.1) | 19/44 (43.2) |
| • Average number of nonrenal subgroup analyses, mean (SD) | 2.8 (4.0) | 2.1 (3.6) |
| • At least 1 subgroup analysis by renal characteristics | 0/135 | 0/44 |
*The sum of the number of trials for each category of exclusion criteria (serum creatinine, eGFR, CrCl, renal replacement therapy, and nonspecific exclusion) is greater than the total number of trials that excluded kidney disease patients, because several trials used multiple concurrent criteria for exclusion of kidney disease (e.g. serum creatinine and renal replacement therapy) and thus were counted for each category. The sum of the percentages is greater than 100% for this reason.
†The sum of the number of trials reporting for each baseline renal parameter (serum creatinine, eGFR, and CrCl) is greater than the total number of trials that reported baseline renal function, because several trials reported multiple renal parameters (e.g. serum creatinine and eGFR) and thus were counted for each category. The sum of the percentages is greater than 100% for this reason.